GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 2795-39-3
Chemical Name Potassium perfluorooctane-1-sulfonate
Substance ID 24A6131
Classification year (FY) FY2012
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link) MHLW Website (in Japanese Only)
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives Not applicable
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - Solid (GHS definition)
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Solid (GHS definition)
5 Gases under pressure Not applicable
-
-
- - Solid (GHS definition)
6 Flammable liquids Not applicable
-
-
- - Solid (GHS definition)
7 Flammable solids Not classified
-
-
- - From the information on perfluorooctane sulfonic acid (NFPA Hazard Classification: Flammability: 0. 0 = Materials that will not burn under typical fire conditions (HSDB (2012))), this substance was judged as not combustible similarly.
8 Self-reactive substances and mixtures Not applicable
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable
-
-
- - Solid (GHS definition)
10 Pyrophoric solids Not classified
-
-
- - From the information on perfluorooctane sulfonic acid (NFPA Hazard Classification: Flammability: 0. 0 = Materials that will not burn under typical fire conditions (HSDB (2012))), this substance was judged as not combustible similarly.
11 Self-heating substances and mixtures Not classified
-
-
- - From the information on perfluorooctane sulfonic acid (NFPA Hazard Classification: Flammability: 0. 0 = Materials that will not burn under typical fire conditions (HSDB (2012))), this substance was judged as not combustible similarly.
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified
-
-
- - There is a metal (K) present in the molecule, but it is estimated that it does not react vigorously with water from water solubility data of 570 mg/L (SIDS: ENV/JM/RD (2002) 17/FINAL (2002)).
13 Oxidizing liquids Not applicable
-
-
- - Solid (GHS definition)
14 Oxidizing solids Classification not possible
-
-
- - The substance is an organic compound containing fluorine and oxygen (but not chlorine), and the oxygen is chemically bonded to the element other than carbon or hydrogen (S, K). However, the classification is not possible due to no data.
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Category 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
It was classified in Category 3 based on an LD50 value of 251 mg/kg for rats (SIDS: ENV/JM/RD (2002)/FINAL).
1 Acute toxicity (Dermal) Classification not possible
-
-
- - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Category 4


Warning
H332 P304+P340
P261
P271
P312
It was classified in Category 4 based on an LC50 value for rats of 5.2 mg/L/1 hour (1.3 mg/L/4 hours) (SIDS: ENV/JM/RD (2002) /FINAL). Because there is a description of exposure to dust as test conditions, a reference value for dust was applied.
2 Skin corrosion/irritation Not classified
-
-
- - No erythema or edema was observed in any animal in a test in which 0.5 or 1 g of the test substance was applied to the skin of six rabbits for 24 or 72 hours, the primary skin irritation score was 0, and there was no irritation (SIDS: ENV/JM/RD (2002) /FINAL). Therefore, it was classified as "Not classified."
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
In a test in which 0.1 g of the test substance was applied to the eyes of six rabbits, the irritation score was maximal 24 hours after the application and then decreased to 0 after 72 hours, and it was concluded that it was irritating (SIDS: ENV/JM/RD (2002) /FINAL). Therefore, it was classified in Category 2B.
4 Respiratory sensitization Classification not possible
-
-
- - No data available.
4 Skin sensitization Classification not possible
-
-
- - No data available.
5 Germ cell mutagenicity Not classified
-
-
- - It was classified as "Not classified" based on a negative result in a micronucleus test with bone marrow after oral administration to mice (in vivo somatic cell mutagenicity test) (GLP) (SIDS: ENV/JM/RD (2002) 17/FINAL). Besides, as for in vitro tests, it is reported that it was negative in both an Ames test and a chromosomal aberration test with human lymphocytes (SIDS: ENV/JM/RD (2002) 17/FINAL).
6 Carcinogenicity Classification not possible
-
-
- - In a test by 104-week diet administration of this substance to rats at concentrations of 0, 0.00005, 0.0002, 0.0005, 0.002%, followed by 52-week diet administration at a concentration of 0.002% and 52-week follow-up, there is a report on increases in the incidences of tumors in the liver, thyroid, mammary gland, but a significant dose-dependent increased trend found in both males and females was limited to hepatocellular adenoma in the liver (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). On the other hand, there is the information on humans that there was no significant increase in the standardized mortality ratio of all cancers (SMR) in the mortality investigation on workers in a PFOS manufacturing plant and a film plant of the same company. And the SMR of bladder cancer in the high exposure group was significantly high (12.77), and the SMR of bladder cancer further increased to 16.12 for workers engaged in the job at least one year, but it is reported that it could not be concluded that this substance was a cause because three male workers with bladder cancer in the high exposure group did not have a longer work history in the department manufacturing this substance (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). From the above, it was classified as "Classification not possible" because the evidence in animals was limited to an increase in hepatocellular adenoma in rats, and there is insufficient evidence of carcinogenicity in humans.
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
In a two-generation reproductive test by oral administration to rats before mating through mating, and during the gestation and lactation period for females, significance was found in shortening of gestation length, a decrease in the number of implantation sites, and an increase in the number of maternal rats with stillbirth or all the pups that died by day 4 at the dose where significantly reduced weight gain was observed as general toxicity (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). And in tests by oral administration to rats and mice during a gestation period, a dose-dependent significant reduction in weight gain and a significant increase in relative liver weights were found (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)), while there were significant increases in the incidences of cleft palate, defects in sternebrae, anasarca, enlarged right atrium, and ventricular septal defects (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). Furthermore, after oral administration to pregnant rats during the organogenesis period, there were significant increases in the incidences of external and visceral malformations (cleft palate, subcutaneous edema, cryptorchidism) at the dose where deterioration of general status was seen including hunchback position, anorexia, and gastrointestinal disturbances as well as deaths of maternal animals (2/25) (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). From the above, it was classified in Category 2 because an increase in deaths of neonates and increased incidences of morphological abnormalities in offspring were observed at the doses that caused general toxicity in parent animals. Besides, it was classified in Repro. Cat. 2; R61 in EU classification (EC-JRC (ESIS) (Access on Oct. 2012)) and B in DFG classification (MAK/BAT (2011)).
8 Specific target organ toxicity - Single exposure Category 1 (systemic toxicity)


Danger
H370 P308+P311
P260
P264
P270
P321
P405
P501
In acute toxicity tests with rats, major signs of hypoactivity, flaccid extremities, and ataxia were observed after oral administration (LD50: 251 mg/kg, doses: 100, 215, 464, and 1,000 mg/kg) (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)), and there is a report on principal signs such as emaciation, red material around the nose or other nasal discharge, dry rales or other breathing disturbances after inhalation administration (dust, LC50 value: 1.3 mg/L/4 hours, doses: 1.89, 2.86, 4.88, 6.49, 7.05, 13.9, 24.09, 45.97 mg/L/1 hour) (SIDS: ENV/JM/RD (2002) 17/FINAL). Doses within the guidance value range for Category 1 were included in both routes, but because it was hard to specify the target organ, it was classified in Category 1 (systemic toxicity).
9 Specific target organ toxicity - Repeated exposure Category 1 (liver, systemic toxicity)


Danger
H372 P260
P264
P270
P314
P501
In a 90-day repeated oral (feeding) administration test with rats (0, 0.003, 0.01, 0.03, 0.1, 0.3%), all the animals died in the groups at or above 0.03% where emaciation, convulsions, hunchback position, irritability, hypoactivity, etc. were observed, necropsy revealed discoloration and swelling of the liver, and hypertrophy and focal necrosis of hepatocytes were marked in males (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). Furthermore, as for the liver, in a 104-week diet administration test with rats at doses all within guidance value range for Category 1 (0, 0.5, 2, 5, 20 ppm), there is a report on significant increases in the incidences of hypertrophy of hepatocytes, vacuolization of hepatocytes, eosinophilic granules, pigment deposit, and necrosis in hepatocytes (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). Therefore, it was classified in Category 1 (liver). On the other hand, as for poisoning signs, it is reported that after 90-day repeated oral administration to monkeys, the animals in the 4.5 mg/kg/day group showed toxicity signs in the gastrointestinal tract such as anorexia, vomiting, and blackish feces from the weeks 1-2, and all the animals had decreased activity, severe rigidity, convulsions, whole body trembling, and prone position immediately before deaths, leading to deaths of all in the weeks 5-7 (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)). The symptoms were seen within the guidance values for Category 1, but because it was hard to specify the target organ, it was classified in Category 1 (systemic toxicity).
10 Aspiration hazard Classification not possible
-
-
- - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 2
-
-
H401 P273
P501
It was classified in Category 2 from 96-hour LC50 = 3.6 mg/L for crustacea (Mysidopsis bahia) (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008); SIDS, 2002).
11 Hazardous to the aquatic environment (Long-term) Category 2


-
H411 P273
P391
P501
If chronic toxicity data are used, then it is classified in Category 2 due to 47-day NOEC = 0.3 mg/L (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)) and 42-day NOEC = 0.3 mg/L (SIDS, 2002) for fish (Pimephales promelas), although it is not rapidly degradable (not readily degradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 due to being not rapidly degradable (not readily degradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and 96-hour LC50 = 3.6 mg/L for crustacea (Mysidopsis bahia) (Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008); SIDS, 2002).
By drawing a comparison between the above results, it was classified in Category 2.
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.

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